Written by Kevin Volz.
Medical device startup VentureMed Group (VMG) is hoping its innovative FLEX Scoring Catheter will reduce the cost of artery-clearing interventional procedures in patients with peripheral artery disease (PAD) globally. The company is starting to do just that for patients abroad thanks to the receipt of a CE mark in October 2015, signifying the product can be sold in Europe.
“The European physicians we’ve worked with have noted that the FLEX Scoring Catheter is a very affordable solution for preparing a patient’s arteries for drug coated balloon or stent intervention. The device is inserted into a patient’s femoral artery and scores the plaque buildup without damaging the wall of the artery,” said Gary Smith, CEO of VMG. “Our next goal is to receive FDA approval so we can offer this same product to physicians in the United States.”
The biggest sales of VMG’s FLEX Scoring Catheter are coming from Germany and Austria, which Smith says are home to the leading vascular surgeons and radiologists in Europe. The company specifically focused their European marketing efforts on these two countries to reach key thought leaders.
To accommodate the growth in the European market, VMG has hired a director of sales and marketing who spends a majority of his time in Europe developing clinical sites and recruiting sales representatives. The company presented its technology at the Leipzig Interventional Course (LINC) conference in Germany in January, and hopes that the exposure will lead to even more international sales leads.
“LINC is the largest conference in the world for PAD,” said Smith. “The demand from this event will allow us to ramp up and hire a team of sales associates to focus specifically on European markets.”
VMG is committed to keeping its headquarters in Toledo, Ohio, and continues to develop its technology in the region. In fact, many of the components used to make the FLEX Scoring Catheter are produced in Ohio.
VMG’s funding for the first-in-man trial of the FLEX Scoring Catheter came from Ohio Third Frontier, specifically the Global Cardiovascular Innovation Center (GCIC) in Cleveland, Ohio. Additional funding and administrative business services for VMG came from Rocket Ventures in Toledo, Ohio. The company is currently in the midst of another fundraising round, which it hopes will total $10 to $15 million by Q3 2016.
Smith’s current focus is on continuing to expand his company into more European markets and preparing for what he hopes will be a smooth FDA clearance process here in the United States.
“We anticipate that our product will be a success in the United States,” said Smith. “The market for products that treat PAD is significant and growing. This is a disease driven by age, smoking, sedentary lifestyle, diabetes and obesity — rates which continue to rise in this country. Our products save hospital systems money and, more importantly, improve patient outcomes.”